Rethinking Meritocracy
Meritocracy—the idea that individuals should advance based on their talent and hard work—appeals to our sense of fairness. However, despite its noble intentions, meritocracy often fails in practice.
How to Manage Painful Customer Experiences
One hour after takeoff from London’s Heathrow Airport on an intercontinental flight to the U.S., the pilot announced the aircraft was returning, “because my windshield just shattered.” After gasps from passengers, he calmly announced there was no danger, but there wo
The Power of Fun at Work
When most people think about work, fun probably isn’t the first word that comes to mind. Deadlines, meetings, and spreadsheets? Sure. But laughter, camaraderie, and a little silliness? That often feels like a luxury, not a priority.
Quality Management During Manufacturing Changes
Change is inevitable in manufacturing. Controlling change effectively distinguishes industry leaders from quality-deficient, recall-plagued, and regulatory-troubled companies.
Building a Strong EQMS Foundation
When organizations implement an enterprise quality management system (EQMS), the instinct is often to begin with high-visibility processes like corrective and preventive action (CAPA) or supplier quality.
Is the Pharmaceutical Industry Missing Out on FMEA?
My June 2025 article, “How to Avoid FDA Warning Letters,” points out that inadequate corrective and preventive action (CAPA) is a major reason
The Importance of Diversifying Your Business
I had a great conversation with a friend of mine. He was bemoaning the fact that his company was almost completely dependent on one huge customer. He saw the inherent risks in that relationship but confessed that his organization had a bad habit it couldn’t kick.
A Guide to 21 CFR Part 11 and Annex 11 Compliant Signatures
We’d be willing to bet your key collaborators aren’t all in the same building. Your team members, contract partners, clients, and suppliers are likely scattered across the globe.
AI and How It Affects the Quality Profession
The use of artificial intelligence (AI) models, specifically generative AI, is growing. This has raised concerns about the effects on jobs in various professions. The quality profession is among them.
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